# K120217: Sonicstimu Combo Therapeutic Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dongdixin Technology Co., Ltd.
- Decided: Nov 21, 2012 after 302 days
- Product code: IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K150436: ComboRehab (2015), 1 descendant of its own
- K244041: Ultrasound Therapy Workstation (XMS-UET2) (2025), 0 descendants of its own

## Indications for use
Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Pain relief, muscle spasms and joint contractures. 2. Relief of pain, muscle spasms and joint contractures that may be associated with: * Adhesive capsulitis * Bursitis with slight calcification * Myositis * Soft tissue injuries * Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic, chronic pain and joint contractures resulting from: " Capsular tightness * Capsular scarring For TENS, Interferential, premodulated(IFC), NMS and Microcurrent 1. Symptomatic relief of chronic intractable pain 2. Post-traumatic acute pain 3. Post-surgical acute pain Additionally for EMS, NMS, Hi-Volt and Russian: 1. Relaxation of Muscle spasms 2. Prevention or retardation of disuse atrophy 3. Increasing local blood circulation 4. Muscle re-education 5. Maintaining or increasing range of motion 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

Source page: https://510kreport.com/device/K120217
Methodology: https://510kreport.com/methodology